- The risk of very bad and sometimes deadly birth defects is very high if your child takes this drug at any time during pregnancy. Any unborn baby can be harmed. There is no good way to tell if an unborn baby has been harmed. The risk of losing an unborn baby is also raised and premature births have happened. The doctor will talk about the bad effects before starting your child on this drug. If your child is going to take this drug during pregnancy, make sure that you know all of the facts about the risks to the unborn baby. If your child is of childbearing age, she must use 2 kinds of birth control to prevent pregnancy 1 month before starting this drug, while taking it, and for 1 month after care ends. A pregnancy test will be done to show that your child is NOT pregnant before starting this drug and every month while she is taking it. If your child gets pregnant while taking this drug or within 1 month after she stops taking it, call the doctor right away.
- This drug may cause a high white blood cell count. Sometimes, this can raise the chance of very bad and sometimes deadly health problems. Your child will be closely watched by the doctor.
- This drug may cause a very bad and sometimes deadly health problem called differentiation syndrome (retinoic-acid-APL syndrome). Most of the time, this problem happens during the first month of taking this drug and sometimes after the first dose. Call the doctor right away if your child has a fever, shortness of breath or trouble breathing; swelling; weight gain; very bad dizziness or passing out; signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes; or signs of kidney problems like not able to pass urine, change in how much urine is passed, or blood in the urine.
- It is used to treat a type of leukemia.
- If your child has an allergy to this drug or any part of this drug.
- If your child is allergic to any drugs like this one or any other drugs, foods, or other substances. Tell the doctor about the allergy and what signs your child had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
- If your child is taking any of these drugs: Demeclocycline, doxycycline, minocycline, tetracycline, a product that has vitamin A in it, a product that is like vitamin A, or St. John’s wort.
If your child is breast-feeding a baby:
- Be sure your child does not breast-feed a baby while taking this drug.
This is not a list of all drugs or health problems that interact with this drug.
Tell the doctor and pharmacist about all of your child’s drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for your child to take this drug with all of his/her drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking with the doctor.
- Tell all of your child’s health care providers that your child is taking this drug. This includes your child’s doctors, nurses, pharmacists, and dentists.
- Have your child avoid tasks or actions that call for alertness until you see how this drug affects your child. These are things like riding a bike, playing sports, or using items such as scissors, lawnmowers, electric scooters, toy cars, or motorized vehicles.
- This drug may cause high cholesterol and triglyceride levels. Talk with the doctor.
- Have your child’s blood work checked often. Talk with your child’s doctor.
- Your child may get sunburned more easily. Avoid lots of sun, sunlamps, and tanning beds. Use sunscreen and dress your child in clothing and eyewear that protects him/her from the sun.
- Blood clots have happened with this drug. Tell the doctor if your child has ever had a blood clot.
- Use with care in children. Talk with the doctor.
If your child is or may be sexually active:
- Be sure your child does not use progestin-only birth control pills (minipills). They may not work well. Talk with the doctor.
- If your child misses her period, has unprotected sex, or thinks that her birth control has not worked, call the doctor right away.
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your child’s doctor or get medical help right away if your child has any of the following signs or symptoms that may be related to a very bad side effect:
- Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Signs of bleeding like throwing up blood or throw up that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; vaginal bleeding that is not normal; bruises without a reason or that get bigger; or any bleeding that is very bad or that you cannot stop.
- Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
- Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
- Change in hearing.
- Hearing loss.
- Swelling of belly.
- A heartbeat that does not feel normal.
- A burning, numbness, or tingling feeling that is not normal.
- Low mood (depression).
- Swelling, warmth, numbness, change of color, or pain in a leg or arm.
- Chest pain or pressure.
- Very bad belly pain.
- Shortness of breath, a big weight gain, or swelling in the arms or legs.
- Feeling confused.
- Hallucinations (seeing or hearing things that are not there).
- Raised pressure in the brain has happened with this drug. This can cause long lasting loss of eyesight and sometimes death. Call the doctor right away if your child has a bad headache, dizziness, upset stomach or throwing up, or seizures. Call the doctor right away if your child has a change in strength on 1 side that is greater than the other, trouble speaking or thinking, change in balance, or blurred eyesight or other change in eyesight.
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child’s doctor or get medical help if any of these side effects or any other side effects bother your child or do not go away:
- Belly pain.
- Upset stomach or throwing up.
- Bone pain.
- Skin irritation.
- Feeling tired or weak.
- Dry mouth.
- Dry eyes.
- Dry skin.
- Dry lips.
- Sweating a lot.
- Hair loss.
- Mouth irritation or mouth sores.
- Not able to sleep.
- Weight gain or loss.
- Not hungry.
- Muscle pain.
These are not all of the side effects that may occur. If you have questions about side effects, call your child’s doctor. Call your child’s doctor for medical advice about side effects.
You may report side effects to your national health agency.
Give this drug as ordered by your child’s doctor. Read all information given to you. Follow all instructions closely.
- Have your child swallow whole. Do not let your child chew, break, or crush.
- To gain the most benefit, do not miss giving your child doses.
- Keep giving this drug to your child as you have been told by your child’s doctor or other health care provider, even if your child feels well.
- Give a missed dose as soon as you think about it.
- If it is close to the time for your child’s next dose, skip the missed dose and go back to your child’s normal time.
- Do not give 2 doses at the same time or extra doses.
- Store at room temperature.
- Protect from light.
- Protect from heat.
- Store in a dry place. Do not store in a bathroom.
- Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
- Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
- If your child’s symptoms or health problems do not get better or if they become worse, call your child’s doctor.
- Do not share your child’s drug with others and do not give anyone else’s drug to your child.
- Keep a list of all your child’s drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your child’s doctor.
- Talk with your child’s doctor before giving your child any new drug, including prescription or OTC, natural products, or vitamins.
- Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your child’s doctor, nurse, pharmacist, or other health care provider.
- If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.
© 2019 Wolters Kluwer Clinical Drug Information, Inc. and its affiliates and/or licensors. All rights reserved.